N/A
N=960
Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
Post-ERCP Acute Pancreatitis
Bottom Line
View on ClinicalTrials.gov: NCT02116309 ↗Enrolled (actual)
960
Serious AEs
0.2%
Results posted
Nov 2017
Primary outcome: Primary: Number of Patients Who Developed Post-ERCP Pancreatitis — 31; 32 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rectal Indomethacin (Drug); Epinephrine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Developed Post-ERCP Pancreatitis |
31; 32 | — |
| SECONDARY Number of Patients Who Developed Severe Post-ERCP Pancreatitis |
4; 7 | — |
Summary
This research is being done to see if using a combination of rectal indomethacin and epinephrine spray during endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).
Eligibility Criteria
Inclusion Criteria
- Major inclusion criteria (If patients meet at least 1 of the criteria):
- History of PEP
- Pancreatic sphincterotomy
- Pre-cut sphincterotomy
- Difficult cannulation (>5 attempts / 10 minutes to cannulate)
- Failed cannulation
- Pneumatic dilation of an intact sphincter
- Sphincter of Oddi dysfunction of Type I or Type II
- Minor inclusion criteria (If patients meet at least 2 of the criteria):
- Age /= 3 pancreatic injections (with at least 1 injection in tail)
- Pancreatic acinarization
- Pancreatic Brush Cytology
Exclusion Criteria
- Unwillingness or inability to consent for the study
- Age 1.4)
- Active or recent (within 4 weeks) gastrointestinal hemorrhage
- Acute pancreatitis (lipase peak) within 72 hours
- Known chronic calcific pancreatitis
- Pancreatic head mass
- Receiving pancreatic duct stent placement for any indication
- Procedure performed on major papilla/ventral pancreatic duct in patients with pancreas divisum
- ERCP for pancreatic/biliary stent removal or exchange without anticipated pancreatogram
- Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
- Anticipated inability to follow protocol
- Sphincter of Oddi dysfunction of Type III
Data sourced from ClinicalTrials.gov (NCT02116309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.